A Study of Vortioxetine (Lu AA21004) in Comparison to Agomelatine in Adults Suffering From Major Depression With Inadequate Response to Previous Medication

NCT01488071 | Completed Phase 3 Results

• 2 other identifiers: 14178A2011-002362-21
• Study Type: interventional
• Target: 495
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the present study is to evaluate whether vortioxetine (10 or 20 mg/day) is at least as effective as agomelatine (25 to 50 mg/day) in patients with depressive symptoms that showed inadequate response to Serotonin Reuptake Inhibitors (SRI) antidepressants.

Conditions

Major Depressive Disorder

Keywords

Depression; Multimodal antidepressant

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in MADRS Total Score at Week 8

  The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 (no symptom) to 6 (severe symptom). The 10 items represent the core symptoms of depressive illness. The rating should be based on a clinical interview with the patient, moving from broadly phrased questions about symptoms to more detailed ones, which allow a precise rating of severity, covering the last 7 days. Total score from 0 to 60. The higher the score, the more severe, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms.

  Baseline and Week 8

Secondary Outcomes (13)

• Change From Baseline in MADRS Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in HAM-A Total Score at Week 8

  Baseline and Week 8

• Change From Baseline in HAM-A Total Score at Week 12

  Baseline and Week 12

• Change From Baseline in CGI-S Score at Week 8

  Baseline and Week 8

• Change From Baseline in CGI-S Score at Week 12

  Baseline and Week 12

Study Arms (2)

Vortioxetine 10 mg or 20 mg

EXPERIMENTAL

Drug: Vortioxetine (Lu AA21004)

Agomelatine 25 mg or 50 mg

ACTIVE COMPARATOR

Drug: Agomelatine

Interventions

Vortioxetine (Lu AA21004) DRUG

encapsulated tablets, daily, orally

Also known as: Brintellix®

Vortioxetine 10 mg or 20 mg

Agomelatine DRUG

encapsulated tablets, daily, orally

Also known as: Valdoxan®

Agomelatine 25 mg or 50 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is being treated with a serotonin reuptake inhibitor (SRI) antidepressant (monotherapy) that was prescribed to treat Major Depressive Episode (DSM-IV-TR criteria)
• The response to the current SRI treatment is inadequate and patient agrees to discontinue the current SRI at the baseline
• Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥22 at the Screening Visit and Baseline
• The patient, if a woman, must: agree not to try to become pregnant during the study, AND use adequate, highly effective contraception

You may not qualify if:

• The patient has any current Axis I disorders (DSM-IV criteria) other than Major Depressive Disorder (MDD), General Anxiety Disorder (GAD) and Social Anxiety Disorder (SAD)
• The patient is at significant risk of suicide
• The patient is currently receiving formal psychotherapy or other psychoactive medications

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Related Publications (3)

• Adair M, Christensen MC, Florea I, Loft H, Fagiolini A. Vortioxetine in patients with major depressive disorder and high levels of anxiety symptoms: An updated analysis of efficacy and tolerability. J Affect Disord. 2023 May 1;328:345-354. doi: 10.1016/j.jad.2023.01.074. Epub 2023 Jan 26.

  PMID: 36708956 DERIVED

• Papakostas GI, Nielsen RZ, Dragheim M, Tonnoir B. Efficacy and tolerability of vortioxetine versus agomelatine, categorized by previous treatment, in patients with major depressive disorder switched after an inadequate response. J Psychiatr Res. 2018 Jun;101:72-79. doi: 10.1016/j.jpsychires.2018.02.017. Epub 2018 Feb 22.

  PMID: 29554497 DERIVED

• Montgomery SA, Nielsen RZ, Poulsen LH, Haggstrom L. A randomised, double-blind study in adults with major depressive disorder with an inadequate response to a single course of selective serotonin reuptake inhibitor or serotonin-noradrenaline reuptake inhibitor treatment switched to vortioxetine or agomelatine. Hum Psychopharmacol. 2014 Sep;29(5):470-82. doi: 10.1002/hup.2424.

  PMID: 25087600 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Vortioxetine; agomelatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: H. Lundbeck A/S
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

+45 36301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 8, 2011
• Study Start: January 1, 2012
• Primary Completion: December 1, 2012
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-02